Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy

• Conditions: Radiotherapy; Adverse Effect; Head and Neck Cancer
• Interventions: Radiation: Radical radiotherapy

• Registration Number: NCT05126095
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss.

Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.

Detailed Description

This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-03
• Study First Submitted: 2021-11-07
• Study First Submitted QC: 2021-11-07
• Study First Posted: 2021-11-18
• Last Update Submitted: 2021-11-21
• Last Update Posted: 2021-12-02
• Primary Completion: 2022-06-14
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers
• Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria

• Previous head and neck radiotherapy
• Previous cervical lymph node dissection
• Active infections
• Palliative treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trial cohort	Radical radiotherapy	CBCT: before radiotherapy and once a week during radiotherapy Body weight: before radiotherapy and once a week during radiotherapy The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy.

Primary Outcome Measures

Name	Time	Method
The treatment-related severe adverse events	7 weeks	The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.

Secondary Outcome Measures

Name	Time	Method
The weight loss percentage	7 weeks	The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy
Scored Patient-Generated Subjective Global Assessment (PG-SGA)	7 weeks	The association between Loss of SMM and PG-SGA in HNC patients during radiotherapy. The PG-SGA scores typically range from 0-35, with a higher score reflecting a greater risk of malnutrition.
the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	7 weeks	The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy
the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)	7 weeks	The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy
Duration ofParenteral nutrition	7 weeks	The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy

Trial Locations

Locations (1)

YI PAN; 🇨🇳 Guangzhou, Guangdong, China